ANTIBACTERIAL FOAMING  - triclosan liquid 
MEIJER DISTRIBUTION INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

ACTIVE INGREDIENT

TRICLOSAN 0.6 PERCENT

PURPOSE

ANTIBACTERIAL

USES

HELPS REDUCE BACTERIA ON THE SKIN.

WARNINGS

FOR EXTERNAL USE ONLY.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES.  IF CONTACT OCCURS, RINSE WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION AND REDNESS DEVELOPS AND LASTS.

DIRECTIONS

PUMP ONTO DRY HANDS, WORK INTO A LATHER AND RINSE THOROUGHLY.

STORE AT ROOM TEMPERATURE.

INACTIVE INGREDIENTS

WATER, SODIUM XYLENESULFONATE, DIPROPYLENE GLYCOL, AMMONIUM LAURYL SULFATE, COCAMIDOPROPYL BETAINE, FRAGRANCE, DISODIUM PHOSPHATE, CITRIC ACID, RED 33 (CI 17200), YELLOW 5 (CI 19140).

image of label

ANTIBACTERIAL FOAMING  
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-183
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-183-08221 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/21/2011
Labeler - MEIJER DISTRIBUTION INC (006959555)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 10/2011
Document Id: 01352fe9-793a-4bfe-ace7-3487483b1bce
Set id: 895e0753-89b8-4f69-80c3-c2a22103dc57
Version: 2
Effective Time: 20111021
 
MEIJER DISTRIBUTION INC